Kornimate/medical-research-clean huggingface dataset:
internet administered cbt for insomnia comorbid with chronic pain

Conditions: Insomnia Due to Medical Condition; Chronic Pain

Summary: cognitive behavioural therapy (cbt), that is designed to be short, concise and user friendly is compared to applied relaxation techniques as treatment for insomnia comorbid with chronic pain. both treatments are administered via internet and participants are randomized to ether treatment arm.

internet treatment with therapist support means that measurements are collected through the internet. participants are recruited from a specialized pain clinic for chronic pain. all patients with sleep complaints (insomnia severity index \> 14) at their first visit through 2016-01-01 to 2017-07-31 are asked for participation via mail. volunteers sign informed consent and undergo a online screening. if matching the inclusion criteria, they are contacted for a telephone interview. subjects are assessed according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criterion for insomnia disorder, m.i.n.i. (screening for psychiatric comorbidity) and the other inclusion/exclusion criteria. the treatment, that is designed to be short, concise and user friendly as it is meant to be usable as an adjunct treatment to other main interventions for chronic pain. the treatment lasts for five weeks and focuses on the most potent cbt technics for insomnia; sleep restriction and stimulus control. randomization is conducted by university staff not otherwise involved in this study. participants have equal chance to be allocated to ether cbt or applied relaxation techniques (active controls). the relaxation treatment lasts for the same amount of time (five weeks) and is designed to require similar weekly effort. both groups fill in sleep diaries every week and weekly feedback is provided by master students supervised by clinical psychologists. the overall hypothesis is that cbt leads to greater symptom reduction (according to the insomnia severity index) compared to applied relaxation techniques.

Eligibility criteria:
inclusion criteria: * insomnia severity index (isi) score \> 14 * chronic pain exclusion criteria: * shift worker or employed as a driver, operator of dangerous equipment and such * sleep apnea, restless legs syndrome, narcolepsy, myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs) * bipolar disorder, psychotic disorders, ongoing substance abuse * having received cbt for insomnia during the latest year * pregnancy * severe somatic disorder (such as ongoing cancer, severe neurological condition, insufficiently treated cardiac condition) * impaired movement to such a degree that going to bed or getting out of bed requires assistance * not being able read or wright in swedish * not having an internet-connected computer, cellular phone or tablet

Keywords: cognitive behavioral therapy applied relaxation techniques internet treatment
treating covid-19 with hydroxychloroquine (teach)

Conditions: COVID-19

Summary: treatments for covid-19 are urgently needed. hydroxychloroquine (hcq) is an antimalarial and immunomodulatory agent being repurposed for covid-19 therapy based off in vitro data suggesting a possible antiviral effect. however, hcq's effect on covid-19 in human infection remains unknown. to fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed covid-19 and randomize them 1:1 to a five-day course of hcq or placebo. notable exclusion criteria include icu admission or ventilation on enrollment, prior therapy with hcq, and baseline prolonged qtc. our primary endpoint is a severe disease progression composite outcome (death, icu admission, mechanical ventilation, ecmo, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (crs) grading scale. secondary exploratory objectives will examine sars-cov-2 viral eradication at the eot, changes in covid-19 putative prognostic markers and cytokine levels, and titers of anti-sars-cov-2 antibodies. this randomized trial will determine if hcq is effective as treatment in hospitalized non-icu patients with covid-19.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. hospitalized adult (≥18 years old) with symptoms consistent with covid-19 including but not limited to any of the following: fever (documented or subjective), cough, dyspnea, diarrhea, nausea, diffuse myalgias, and/or anosmia 2. informed consent signed by patient 3. positive sars-cov-2 rt-pcr testing (nasopharyngeal, oropharyngeal, sputum and/or bronchoalveolar lavage) o the testing may: * occur up to ≤72h prior to informed consent of participation in the study * be undertaken either on-site or in an external laboratory certified by new york state to run testing for sars-cov-2 exclusion criteria an individual who meets any of the following criteria will be excluded from participation in this study: 1. presence of the primary endpoint (icu admission, mechanical ventilation, ecmo, and/or vasopressor requirement) at time of randomization. 2. treatment with cq or hcq within the 30 days prior to the start of the study drug treatment. 3. participation in a clinical trial to investigate a non-fda approved drug with the intent to treat sars-cov-2 within the 30 days prior to the start of the study drug treatment. 4. unable to take oral medications. 5. history of allergic reaction or intolerance to cq or hcq. 6. baseline corrected qt interval \>470 milliseconds (male) or \>480 milliseconds (female), history of congenital qt prolongation, and/or history of cardiac arrest. 7. concomitant therapy with flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, or pimozide 8. history of retinal disease including a documented history of diabetic retinopathy. 9. known history of g6pd deficiency.
efficacy and safety of petrelintide in participants with overweight or obesity and type 2 diabetes (zupreme 2)

Conditions: Overweight; Type 2 Diabetes; Obesity

Summary: the main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.


Eligibility criteria:
main inclusion criteria: * male or female participants with body mass index (bmi) ≥27.0 kg/m2. * diagnosed with type 2 diabetes ≥180 days prior to the day of screening. * treated with metformin with or without sodium-glucose cotransporter 2 inhibitors. treatment should be stable (same drug\[s\], dose, and dosing frequency) for at least 90 days prior to screening. main exclusion criteria: * severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness. * receipt of any other glucose-lowering drug than those listed in the inclusion criterion within 90 days prior to screening. * a self-reported change in body weight \>5% within 90 days prior to screening, irrespective of medical records. * treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 6 months prior to screening. * previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. however, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g., sleeve, banding, or similar) that have been removed more than 6 months prior to screening, are allowed. * obesity due to endocrine disorders or genetic syndromes.

Keywords: long-acting amylin analogues weight management
changing the surgical team for wound closure and surgical site infection

Conditions: Incidence of Surgical Site Infection; Morality; Fascial Hernia

Summary: surgical site infection is a frequent complication after abdominal surgery. the wound closure is done at the end of the procedure when the attention of the entire team may be affected because of tiredness and reduced attention of the surgical team. with this study, the investigators aim to test if an exchange of the surgical team by a specialised wound closure team may reduce the impact of surgical site infection.


Eligibility criteria:
inclusion criteria: * general consent as documented by signature * patients undergoing elective or emergency abdominal surgery from monday to friday with wound closure from 8:00 until 17:30 and duration of operation. * age over 18 years exclusion criteria: * patients \< 18 years of age * patients with preexisting ssi

Keywords: surgical site infection changing the surgical team
proprotein convertase subtilisin kexin 9 in rheumatoid arthritis

Conditions: PCSK9

Summary: rheumatoid arthritis (ra) has been proved to increase the incidence of atrial fibrillation (af) with persistent systemic inflammation. proprotein convertase subtilisin/kexin type 9 (pcsk9) has been found to enhance the production of pro-inflammatory cytokines. therefore, we performed the present study to observe the expression and significance of proprotein convertase subtilisin kexin 9 (pcsk9) in patients with ra combined atrial fibrillation.

atrial fibrillation (af), the most common clinically relevant arrhythmia, is an important contributor to population morbidity and mortality. rheumatoid arthritis (ra) is a chronic systemic inflammatory disease, which affects approximately 1% of the population. increasing studies demonstrated that ra had a positive correlation with increased cardiovascular diseases. increasing studies showed that the prevalence of af is significantly higher in ra patients than in the general population. recently, some studies indicated that proprotein convertase subtilisin/kexin type 9 (pcsk9) promotes inflammatory by regulating macrophage secretion of inflammatory cytokines, inducing c-reaction protein (crp), interleukin (il)-6, il-8, tumor necrosis factor-α (tnf-α) and so on. however, the levels of pcsk9 in atrial fibrillation patients with rheumatoid arthritis is still unclear. therefore, the aim of this study was to assess the expression of pcsk9 in patients with ra combined atrial fibrillation.

Eligibility criteria:
inclusion criteria: 1. rheumatoid arthritis 2. rheumatoid arthritis combined with af exclusion criteria: 1. (1) history of hypertension, diabetes, cardiovascular disease, severe impairment of liver function, severe renal insufficiency. (2) infectious diseases. (3) history malignant tumor. (4) pregnant women, lactating women. (5) other autoimmune diseases. 2. (1) history of hypertension, diabetes, cardiovascular disease (except for af), severe impairment of liver function, severe renal insufficiency. (2) infectious diseases. (3) history malignant tumor. (4) pregnant women, lactating women. (5) other autoimmune diseases.

Keywords: atrial fibrillation rheumatoid arthritis pcsk9
unicompartmental knee arthroplasty vs. high tibial osteotomy for medial knee osteoarthritis (unikorn): a study protocol of a randomized controlled trial

Conditions: Knee Osteoarthritis

Summary: unicompartmental knee arthroplasty (uka) and high tibial osteotomy are both valid treatment options for isolated medial knee osteoarthritis. literature to date is lacking high grade evidence of the outcomes between these procedures. this is a study protocol for randomized controlled trial comparing uka vs hto in late stage medial knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * isolated kl 3-4 medial knee arthrosis * varus \> 3 degrees * age 45-65 years exclusion criteria: * post-traumatic arthrosis * arthrosis in the lateral compartment more than kl grade i in mri * post- traumatic arthrosis * instability * malignancy obesity
effectiveness gastric balloon in obese adolescents

Conditions: Obesity, Morbid

Summary: assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.


Eligibility criteria:
inclusion criteria: * clinically obese or morbid obese males and females aged 14 - 19 years old (bmi \> 3.5 sd) * are able to attend biweekly to monthly sessions with our support team and are capable of adhering to the lifestyle changes advised exclusion criteria * previous esophageal or gastric surgery or history of intestinal obstruction; * history of moderate to severe inflammatory disease of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or stenosis; gastric or esophageal varices; congenital or acquired intestinal telangiectasis * hiatus hernia \>5 cm or \<5cm with associated severe or intractable gastro-esophageal reflux symptoms (assessed at balloon insertion); * history of significant psychological disorder (permission sought from lead care giver).
searching biomarkers cerebral amyloid angiopathy (seneca)

Conditions: Cerebral Amyloid Angiopathy

Summary: cerebral amyloid angiopathy (caa) is one of the major types of cerebral small vessel disease, and a leading cause of spontaneous intracerebral hemorrhage and cognitive decline in elderly patients. although increasingly detected, a number of aspects including the pathophysiology, the clinical and neuroradiological phenotype and the disease course are still under investigation. the incomplete knowledge of the disease limits the implementation of evidence based guidelines on patient's clinical management and the development of treatments able to prevent or reduce disease progression. the seneca (searching biomarkers of cerebral angiopathy) project is the first italian multicentre cohort study aimed at better defining the disease natural history and identifying clinical and neuroradiological markers of disease progression. by a multidisciplinary approach and the collection of a large and well phenotyped series and biorepository of caa patients, the study is ultimately expected to improve the diagnosis and the knowledge of caa pathophysiological mechanisms.

the seneca is an italian multicenter network integrating the experience of neurologists, neuroradiologists, neuro-ophthalmologists and biologists and allowing the standardized collection of a well-characterized wide series of sporadic and familial caa patients.

Eligibility criteria:
inclusion criteria: * all consecutive patients ≥55 years (with the exception of genetic cases), referred to the participating centres, with a diagnosis of possible probable and definite symptomatic or asymptomatic caa, defined according to the modified boston neuroradiological criteria, who had undergone at least one brain mri (mandatory requirement for inclusion of the patient in the study) will be recruited. exclusion criteria: * evidence of other causes of cerebral hemorrhage (brain tumors, arteriovenous malformations, aneurysms, cavernous angiomas), contraindications to brain mri, pregnancy and breastfeeding
neurofeedback for internet gaming addiction

Conditions: Internet Gaming Disorder

Summary: the primary aim of this study is to evaluate the therapeutic potential of real-time functional magnetic resonance imaging (mri) neurofeedback in alleviating internet gaming disorder (igd) symptoms by training individuals with such symptoms to down-regulate the activity in their reward-processing-related midbrain regions.


Eligibility criteria:
inclusion criteria: * meet at least five of the diagnostic and statistical manual of mental disorders fifth edition (dsm-5) criteria for igd and score 38 or above on the internet addiction test (iat) * first language is chinese (mandarin) * right-handed * have played the mobile game "king of glory" for more than 3 years * ability to give informed consent * normal or corrected-to-normal vision exclusion criteria: * any primary diagnosis of a current psychological or neurological disorder * any history of psychological or neurological disorder * any mri contraindication * currently on a psychotropic medication * any history of substance dependence * any history of brain injury or surgery

Keywords: neurofeedback behavior addiction
evaluation of the bimatoprost implant system used in combination with the spyglass intraocular lens compared to timolol ophthalmic solution

Conditions: Cataract; Glaucoma; Ocular Hypertension

Summary: this trial is a randomized study to evaluate and compare two doses of the bimatoprost implant system used in combination with the spyglass iol to timolol ophthalmic solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.


Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate open-angle glaucoma or ocular hypertension * planned removal of cataract * female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception exclusion criteria: * uncontrolled systemic disease * history of incisional/refractive corneal surgery * any glaucoma diagnosis other than oht, open-angle, pseudoexfoliation, or pigmentary glaucoma * history of incisional glaucoma surgery or intraocular injections * other ocular diseases, pathology, or conditions
pain and schizophrenia

Conditions: Pain; Schizophrenia

Summary: the aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. the investigators will couple methods of experimental psychology with eeg and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.


Eligibility criteria:
inclusion criteria: * patients with schizophrenia (criteria dsm iv) or healthy controls matched with patients on age, sex and education level * 18-55 years old exclusion criteria: * past history affecting cns * intake of psychotropic drugs, except for patients * metabolic disorder affecting sensory processing (diabetes) * intake of benzodiazepines

Keywords: schizophrenia dsm iv criteria pain insensitivity painful perception opioid receptors
effect of varied outreach methods on appointment scheduling, appointment completion, and receipt of mmr vaccination

Conditions: Preventable Disease, Vaccine; Health Care Utilization

Summary: our objective is to determine the effectiveness of varied outreach methods (e.g. automated reminder calls/text messages with or without personalized calls/texts) to children age 12-14 months or 4 years old who are due for a wcc visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the mmr vaccination.


Eligibility criteria:
inclusion criteria: * age: 12-14 months old or 4 years old * has not yet received first mmr (for 12-14 month olds) or second mmr (for 4 year olds) * has not had a well child check in past 365 days (for 4 year olds) * no appointment scheduled in the next 45 days * parent preferred language = english or spanish exclusion criteria: * phone number not available in electronic medical record
gb1275 monotherapy and in combination with an anti-pd1 antibody in patients with specified advanced solid tumors or in combination with standard of care in patients with metastatic pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma; Esophageal Adenocarcinoma; Esophageal Squamous Cell Carcinoma; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Triple Negative Breast Cancer; Castration-resistant Prostate Cancer; Microsatellite Stable Colorectal Cancer; Non-small Cell Lung Cancer; Small-cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Urothelial Carcinoma; Renal Cell Carcinoma; Hepatocellular Carcinoma

Summary: this first-in-human (fih ) study is an open-label, multicenter study that consists of a phase 1 dose escalation/expansion phase of gb1275 monotherapy or in combination with anti-pd-1 antibody or in combination with standard of care in patients with metastatic pancreatic adenocarcinoma followed by a phase 2 basket expansion phase in patients with specified metastatic solid tumors

note: the phase 2 portion of the study was not initiated.

Eligibility criteria:
inclusion criteria: * subject has a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) performance scale. * women of childbearing potential must use an acceptable method of contraception phase 1 subjects with the the following: * regimen a and b: * pancreatic adenocarcinoma, * esophageal adenocarcinoma, or esophageal squamous cell carcinoma, or * gastric/gastroesophageal junction adenocarcinoma, or * tnbc, or * prostate cancer, or * colorectal adenocarcinoma, or subjects with tumor types that have progressed after receiving initial treatment benefit rom the last single agent checkpoint inhibitor that is approved for the indication or in combination with standard of care therapy, for example, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, renal cell carcinoma, and hepatocellular carcinoma, etc. * regimen c: newly diagnosed stage iv pancreatic cancer phase 2 * cohort 1: pancreatic cancer. * cohort 2: colorectal cancer * cohort 3: gastric/gej adenocarcinoma exclusion criteria: * history of another malignancy within 2 years prior to first study drug(s) administration, unless the malignancy was treated with curative intent and the likelihood of relapse is \<5% in 2 years * pregnant or nursing * known history of testing positive for human immunodeficiency virus (hiv) * gastrointestinal (gi) tract disease causing the inability to take oral medication. * positive test for hepatitis b virus surface antigen (hbsag) or a and/or positive hep c antibody result with detectable hepatitis c virus (hcv) ribonucleic acid (rna) indicating acute or chronic infection. other protocol-defined inclusion/exclusion criteria will apply

Keywords: gej adenocarcinoma tnbc mss mcrc pd-l1 + gastric cancer pd-l1 positive gastric cancer nsclc sclc newly diagnosed stage iv pancreatic adenocarcinoma hcc rcc hnscc transitional cell carcinoma